Zhongshan Mainstream Source Biotechnology Co., Ltd.

I期 主要研究目的：评价MB0151在晚期实体瘤受试者中的安全性和耐受性；确定发生DLT的受试者数量和百分比，或确定最大耐受剂量；确定剂量扩展研究的最佳生物剂量或推荐剂量。次要研究目的：评价晚期实体瘤受试者接受MB0151单次和多次静脉输注给药后的药代动力学；评价MB0151受关注的不良事件；评价MB0151在晚期实体瘤受试者中的潜在免疫原性；评价MB0151在晚期实体瘤受试者中的初步抗肿瘤活性。 II期 主要研究目的：评价MB0151在晚期实体瘤受试者中的初步抗肿瘤活性。次要研究目的：评价晚期实体瘤受试者接受MB0151静脉给药的安全性；考察晚期实体瘤受试者接受MB0151静脉给药的药代动力学；评估MB0151在晚期实体瘤受试者中的潜在免疫原性。

This is a multicenter, open-label, single-arm, dose-escalation and dose-expansion Phase I/II study to evaluate the safety, tolerability and preliminary anti-tumor activity of MB0151 in adult subjects (at least 18 years old) with advanced solid tumors. This study includes two phases: dose escalation and dose expansion. In this study, the protocol of accelerated titration combined with i3+3 is used for dose escalation,administered intravenously every 2 weeks. Enrolled subjects will be sequentially assigned to the planned dose cohorts according to this protocol to receive MB0151 treatment and will be monitored for the occurrence of DLT. The RP2D and/or OBD will be determined by considering the PK profile, safety and efficacy data in the dose-escalation stage (including backfill cohorts). The recommended dose and tumor types for the expansion cohorts will be determined based on the safety and efficacy outcomes of subjects treated in the Phase I dose-escalation study. In each expansion cohort, approximately 30 subjects will receive MB0151 treatment for up to 6 cycles by IV infusion on D1 and D15 of each cycle . When the subject has completed a total of 6 cycles (24 weeks) of treatment, if he/she is judged by the investigator to show clinical benefit and signs the ICF (for expansion period), and does not meet the stopping criteria, MB0151 treatment can be continued unless disease progression criteria are met, intolerable toxicity occurs or informed consent is withdrawn (whichever occurs first).